MAUDE Adverse Event Report: SYNTHES MONUMENT T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD; SCREWDRIVERS

Catalog Number	03.632.004
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Device is an instrument and is not implanted/explanted.Part # 03.632.004 synthes lot # 7575336.Release to warehouse date: 07-aug-2014.Supplier: (b)(4).Nonconformance #(b)(4) was launched for failure by the inspection engineer to perform the final inspection.A sample of 13 items of the lot were reworked through reinspection and all items passed.This ncr is not relevant to the complaint condition as this is a documentation/inspection issue.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a t-handle t25 stardrive shaft was stripped at the tip, the sleeve threads of a holding sleeve-standard with stop for matrix were stripped, the tip of the t-pal trial spacer has broken off, the tip of the t-pal spacer applicator has broken off, and the slap hammer broke into (2) pieces at the very lowest part of the hammer.This was discovered during routine inspection.There is no patient or case involved.This is report 1 of 5 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: product investigation was completed.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.The t-handle was returned with four (4) of the flutes gouged.The t-handle t25 stardrive shaft is one of ten t25 driver shafts intended to be utilized for screw insertion in the matrix system.Of the ten t25 drivers available in the system, only four are intended for final tightening of the ten t25 drivers available in the system, only four are intended for final tightening and a countertorque.The following caution is noted: ¿never use fixed or ratcheting t-handle screwdriver for this technique.If the torque limiting attachment is not used when using any of the stardrive shaft options breakage of the driver may occur and could potentially harm the patient.¿ relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.As the circumstances leading to the damage is not known, the definitive root cause could not be determined, however, the failure mode is consistent with the application of excessive force over the course of use.Device mfr date: aug 07, 2014.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 1 of 6 for (b)(4).

• Brand Name: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6311818
• Report Number: 1719045-2017-10085
• Device Sequence Number: 913361
• Product Code: HXX
• UDI-Device Identifier: 10705034718699
• UDI-Public: (01)10705034718699(10)7575336
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.632.004
• Device Lot Number: 7575336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1